BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8405747 · Received March 8, 2019

    Report

    Report Number
    3004209178-2019-04875
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 18, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# V012723, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# VA0935Y, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 22-APR-2021, UDI# (B)(4); PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 23-MAR-2021, UDI # (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: V012723, UBD: 22-MAY-2009, (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: VA0935Y, UBD: 05-MAR-2016, UDI # (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY WERE UNABLE TO LEARN OF THE PATIENT¿S WEIGHT SINCE THEY WEREN'T PRESENT AT THEIR SURGERY. NO FURTHER COMPLICATIONS WERE ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT'S FULL SYSTEM WAS REMOVED DUE TO EROSION AT THE LEAD/CONNECTION SITE. THE HARDWARE ERODED AT THE LEAD AND OVER ONE OF HER EXTENSIONS. SURGEON HAD NO ALTERNATIVE OTHER THAN EXPLANT ALL OF HER HARDWARE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED. NO DIAGNOSTICS/TROUBLESHOOTING WAS DONE. INTERVENTIONS/ACTIONS INCLUDED EXPLANT OF HARDWARE. THE ISSUE IS REPORTED TO BE RESOLVED. THE HARDWARE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197411 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention